Section 11-850-72 - Manufactured cannabis products(a) A dispensary licensee may manufacture cannabis products limited to: (1) Edible cannabis products as specified in section 11-850-76;(2) Ointments and skin lotions;(4) Pre-filled and sealed containers used to aerosolize and deliver cannabis orally, such as with an inhaler or nebulizer; provided that the containers need not be manufactured by the licensed dispensary but:(A) Shall be filled only with cannabis, cannabis oils, or cannabis extracts manufactured by a dispensary licensee;(B) Shall not contain nicotine, hemp, hemp-derived cannabinoids, tobacco-related products or any non-cannabis derived products; and(C) Shall be designed to be used with devices used to provide safe pulmonary administration of manufactured cannabis products;(5) Devices that provide safe pulmonary administration; provided that: (A) The heating element of the device, if any, is made of inert materials such as glass, ceramic, or stainless steel, and not of plastic or rubber;(B) The device is distributed solely for use with single-use, pre-filled, tamper-resistant, sealed containers that do not contain nicotine, other tobacco products, hemp, or hemp-derived cannabinoids;(C) The device is used to aerosolize and deliver cannabis by inhalation, such as an inhaler, medical-grade nebulizer, or other similar medical grade volatilization device;(D) There is a temperature control on the device that is regulated to prevent the combustion of cannabis oil; and(E) The device need not be manufactured by the licensed dispensary; and(6) Pre-rolled cannabis flower products as specified in section 11-850-79.(b) A dispensary licensee shall establish and maintain written standard operating procedures for the manufacturing, analysis, sale, security, storage, inventory tracking, transportation, and disposal of manufactured cannabis products that includes but is not limited to: (1) Safe and appropriate use of manufacturing equipment;(2) Safe and appropriate storage of materials used to produce manufactured cannabis products;(3) Effective training and monitoring of employees and subcontractors who participate in the manufacturing or dispensing of manufactured cannabis products;(4) Adequate protocols for laboratory analysis of manufactured cannabis products pursuant to this chapter; and(5) Safe and appropriate storage and disposal or destruction of manufactured cannabis products at all stages of production and sale.(c) A dispensary licensee shall report to the department prior to producing any manufactured cannabis products: (1) Strains of cannabis to be used by the dispensary to produce manufactured cannabis products;(2) Types of manufactured cannabis products that the dispensary will produce; and(3) The manufacturing process or processes the dispensary will use in producing manufactured cannabis products.(d) Prohibited ingredients. (1) Except for alcohol in tinctures and caffeine naturally occurring in chocolate, no manufactured cannabis product shall contain tobacco, nicotine, caffeine, alcohol, or any other substance not derived from cannabis that:(B) Would increase the potency, toxicity, or addictive potential of the product or create a potentially unsafe combination with cannabinoids.(2) No manufactured cannabis product shall contain:(A) Synthetic cannabinoids; or(B) Artificially derived cannabinoids.(3) No aerosolizeable manufactured cannabis product shall contain zirconium.(4) No manufactured cannabis product shall contain:(A) Any color additives not listed in subpart A or C of 21 C.F.R. part 73, published by the U.S. Government Publishing Office, as amended as of April 1, 2021;(D) Halogenated salicylanilides listed in 21 C.F.R. section 700.15, published by the U.S. Government Publishing Office, as amended as of April 1, 2021;(G) Prohibited cattle material, as defined in 21 C.F.R. section 700.27, published by the U.S. Government Publishing Office, as amended as of April 1, 2021;(J) Ephedrine alkaloids; or(K) Any ingredient the department determines would render the product injurious or hazardous to health.(e) Prohibited components. Except for ointments intended for topical application, skin lotions, and transdermal patches, manufactured cannabis products shall not be manufactured with any components that are not intended to be safe for use in manufacture of a product for human consumption. Additives used as components in the production of manufactured cannabis products, except for ointments intended for topical application, skin lotions, and transdermal patches, shall be limited to those allowed for use in food in section 11-29-8.(f) A dispensary licensee shall not produce manufactured cannabis products with an appearance, flavor, or smell designed to appeal to minors.(g) The director may require quarantine, removal, or modification of a manufactured cannabis product determined to present a potential health hazard.[Eff DEC 14 2015] (Auth: HRS §§ 321-9, 329D-27) (Imp: HRS §§ 329D-6, 329D-7, 329D-9, 329D-10)[Am and comp 2/24/2022] (Auth: HRS §§ 321-1, 329D-7, 329D-8, 329D-9, 329D-10) (Imp: HRS §§ 329D-8, 329D-17; SLH 2017, Act 170, §3)